Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01785329
First received: January 30, 2013
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

Primary Objective:

To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects.

Secondary Objectives:

  • To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and apolipoproteins.
  • To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).
  • To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553 (REGN727).

Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized Study of the Relative Bioavailability, Pharmacodynamics, Safety of SAR236553 (REGN727) After Single Subcutaneous Administration at 3 Different Injection Sites in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of the serum concentrations of alirocumab SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of the number of subjects with adverse events after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of alirocumab SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727) - Dose A

alirocumab SAR236553 (REGN727) - Dose A - Injection in healthy subjects through subcutaneous administration in the abdomen.

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose B
alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose C
alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Detailed Description:

Total duration of the study per subject is about 15 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy subjects.

Exclusion criteria:

Healthy subjects with history or presence of clinically relevant illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785329

Locations
United Kingdom
Investigational Site Number 826001
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01785329     History of Changes
Other Study ID Numbers: BDR13362, 2012-005005-40, U1111-1134-2618
Study First Received: January 30, 2013
Last Updated: August 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014